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Metastatic Colorectal CancerPhase 1/2ARC-9NCT04660812

An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.

A Phase 1/2 study testing AB680, Etrumadenant and Zimberelimab in people with Metastatic Colorectal Cancer, run by Arcus Biosciences, Inc. at 44 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase 1b/2 open-label study will evaluate the antitumour activity and safety of etrumadenant (AB928) treatment combinations in participants with metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
AB680, Etrumadenant and Zimberelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
227 participants
Where
44 sitesin 6 countries
Study dates
10 May 2021to 5 Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female participants ≥ 18 years of age
  • Histologically confirmed metastatic colorectal adenocarcinoma
  • Must have at least 1 measurable lesion per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy at least 3 months
  • Adequate hematologic and end-organ function
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  • Negative HIV, Hep B and Hep C antibody testing
  • Agreement to remain abstinent or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, for 30 days after the last dose of etrumadenant, 90 days after the last dose of zim, 180 days after mFOLFOX-6 and 180 days after bev, whichever is longer.
  • Disease progression following not more than one prior line of treatment for mCRC that consisted of oxaliplatin or irinotecan containing chemotherapy in combination with a biologic agent
  • Disease progression during or following not more than two separate lines of treatment for mCRC that consisted of oxaliplatin, and irinotecan containing chemotherapy in combination with a biologic agent

Who cannot join

  • Previous anticancer treatment within 4 weeks prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplant
  • Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
  • Use of any live vaccines against infectious diseases within 28 days of first dose.
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Current treatment with anti-viral therapy for HBV
Show all 23Show fewer
  • Structurally unstable bone lesions suggesting impending fracture
  • History or leptomeningeal disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • History of malignancy other than colorectal cancer within 2 years prior to screening, except for malignancies such as non-melanoma skin carcinoma or ductal carcinoma in situ
  • Active tuberculosis
  • Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiating study treatment
  • Severe infection within 4 weeks (28 days) prior to initiation of study treatment
  • Significant cardiovascular disease, unstable or new onset of angina within 3 months prior to initiation of treatment, or myocardial infarction within 6 months prior to study treatment or unstable arrhythmia
  • Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for major surgical procedure during the study
  • Known allergy or hypersensitivity to any of the study drugs or their excipients
  • Inability to swallow medications
  • Malabsorption condition that would alter the absorption of orally administered medications
  • Evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
  • Prior treatment with an agent targeting the adenosine pathway
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain Barré syndrome, or multiple sclerosis
  • Prior treatment with immune checkpoint blockade therapies including anti-cytotoxic T lymphocyte-associated protein-4, anti PD-1, and anti-PD-L1 therapeutic antibodies
  • Mutation in the BRAF oncogene. Patients with unknown BRAF status will be required to undergo testing at a local laboratory and provide results at screening

Trial locations and contacts

44 sites in 6 countries.

44 sites in 6 countries

United States17 sites

  • Winship Cancer Institute at Emory University

    Atlanta, Georgia, 30322

  • American Oncology Partners of Maryland PA

    Bethesda, Maryland, 20817

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Prisma Health-Upstate

    Greenville, South Carolina, 29605

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Centers Of Nevada

    Las Vegas, Nevada, 89169

  • University of Wisconsin School of Medicine

    Madison, Wisconsin, 53792

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37203

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37232

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Ochsner Medical Center (OMC)

    New Orleans, Louisiana, 70121

  • NYU Langone Medical Center - NYU Medical Oncology Associates

    New York, New York, 10016

  • New York-Presbyterian Hospital-Columbia University Medical Center

    New York, New York, 10032

  • UCLA Hematology Oncology

    Santa Monica, California, 90404

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Arizona Clinical Research Center Inc

    Tucson, Arizona, 85715

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016-2633

Other trials in United States

South Korea8 sites

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Seoul National University Bundang Hospital

    Seoul, 13620

  • Seoul National University Hospital (SNUH)

    Seoul, 3080

  • Severance Hospital | Yonsei University Health System

    Seoul, 3722

  • Asan Medical Center | University of Ulsan College of Medicine

    Seoul, 5538

  • Samsung Medical Center

    Seoul, 6351

  • Korea University Anam Hospital

    Seoul, 8241

  • Kyungpook National University Chilgok Hospital

    Seoul

Other trials in South Korea

France6 sites

  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, 33076

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • Hopital Hotel Dieu

    Nantes, 44093

  • Hopital Saint Antoine

    Paris, 75012

  • Groupe Hospitalier Pitie-Salpetriere-Centre De Recherche et de Medecine de l'Obesite

    Paris, 75651

  • CHU la Miletrie

    Poitiers, 86000

Other trials in France

Italy6 sites

  • IRCCS - Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    Castellana Grotte, 70013

  • Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica

    Florence, 50134

  • Azienda Ospedaliera Niguarda Ca' Granda

    Milan, 20141

  • Instituto Europeo di Oncologia

    Milan, 20162

  • Istituto Clinico Humanitas IRCCS

    Rozzano, 20089

  • Universita di Siena - Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

    Siena, 53100

Other trials in Italy

Spain5 sites

  • Hospital Universitario La Paz

    Madrid, 28007

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28046

  • Complejo Hospitalario de Orense

    Ourense, 32005

  • Clinica Universidad Navarra-Sede Madrid

    Pamplona, 31008

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 8208

Other trials in Spain

United Kingdom2 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB

Other trials in United Kingdom

About this study

Official title: A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating The Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer

This randomized phase 1b/2 open-label study will evaluate the antitumour activity and safety of etrumadenant (AB928) treatment combinations in participants with metastatic colorectal cancer.

Read the detailed description

This is a multicenter, open-label Phase 1b/2 study in participants with metastatic colorectal cancer that will assess the antitumour activity and safety of etrumadenant.

Approximately 250 participants will be enrolled to 1 of 3 cohorts:

Cohort A) etrumadenant + zimberelimab +mFOLFOX-6 +/-bevacizumab vs mFOLFOX-6 +/-bevacizumab

Cohort B) etrumadenant + zimberelimab +mFOLFOX-6 +/-bevacizumab vs regorafenib

Cohort C) chemotherapy-free combinations of etrumadenant + zimberelimab + other agents

The primary objective of this clinical study is to evaluate the safety of etrumadenant-based combination therapy in participants with metastatic colorectal cancer.

Being tested
AB680, Etrumadenant, Zimberelimab, Bevacizumab, m-FOLFOX-6 regimen
Keywords
mCRC
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AB680Drug

    AB680 is a cluster of differentiated CD73 Inhibitor

  • EtrumadenantDrug

    Also called AB928

    Etrumadenant is a dual adenosine receptor (A2aR and A2bR) antagonist

  • ZimberelimabDrug

    Also called AB122

    Zimberelimab is a fully human anti-PD-1 monoclonal antibody

  • BevacizumabDrug

    Bevacizumab is administered as part of standard chemotherapy regimen

  • m-FOLFOX-6 regimenDrug

    mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen

  • RegorafenibDrug

    Regorafenib is administered as part of standard chemotherapy regimen

Study groups in NCT04660812
Study groupRoleWhat they receive
Etrumadenant + Zimberelimab + mFOLFOX-6 +/- BevacizumabExperimentalParticipants will receive oral etrumadenant in combination with zimberelimab +mFOLFOX-6 +/-bevacizumab by IV infusion.
Receives: Drug: Etrumadenant; Drug: Zimberelimab; Drug: Bevacizumab; Drug: m-FOLFOX-6 regimen
mFOLFOX-6 +/- BevacizumabActive comparatorParticipants will receive mFOLFOX-6 +/- bevacizumab by IV infusion.
Receives: Drug: Bevacizumab; Drug: m-FOLFOX-6 regimen
RegorafenibActive comparatorParticipants will receive oral regorafenib
Receives: Drug: Regorafenib
AB680 + Etrumadenant + ZimberelimabExperimentalParticipants will receive oral etrumadenant in combination with AB680 + zimberelimab by IV infusion.
Receives: Drug: AB680; Drug: Etrumadenant; Drug: Zimberelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort A and B - Progression-free Survival (PFS)

    PFS according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the Investigator

    Measured: From randomization until death from any cause (up to approximately 3-7 years)

  2. Cohort C - Objective Response Rate (ORR)

    ORR according to RECIST v1.1, as assessed by the Investigator

    Measured: From randomization until death from any cause (up to approximately 3-7 years)

  3. Number of Participants With Treatment-emergent Adverse Events

    Measured: Up to approximately 10 Months

Secondary outcomes (14)

  1. Cohorts A and B - Objective Response Rate (ORR)

    ORR according to RECIST v1.1 as assessed by the Investigator

    Measured: From randomization until death from any cause (up to approximately 3-7 years)

  2. Cohorts A, B, and C- Duration of Disease Response (DoR)

    DoR according to RECIST v1.1, as assessed by the Investigator

    Measured: From randomization until death from any cause (up to approximately 3-7 years)

  3. Cohorts A, B, and C- Disease Control Rate (DCR)

    DCR according to RECIST v1.1, as assessed by the Investigator

    Measured: From randomization until death from any cause (up to approximately 3-7 years)

  4. Cohorts A and B - Overall Survival (OS)

    OS according to RECIST v1.1, as assessed by the Investigator

    Measured: From randomization until death from any cause (up to approximately 3-7 years)

  5. Observed Maximum Concentration (Cmax) of Etrumadenant and its Metabolites

    Cycle 1 Day 1 and Cycle 2 Day 1

    Measured: From randomization until death from any cause (up to approximately 10 months)

  6. Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours [AUC(0-24)] of Etrumadenant and its Metabolites

    Measured: Up to 24 hours following Day 1 Cycle 1 and Cycle 2 (each cycle is 28 days)

  7. Trough Concentrations of Etrumadenant and its Metabolites

    Measured: Multiple timepoints up to approximately 16 months

  8. Cmax End of Infusion (EOI) of AB680

    Measured: At the end of infusion on Day 1 Cycle 1 and Cycle 2 (each cycle is 28 days)

  9. Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours [AUC(0-336)] of AB680

    Measured: Up to 336 hours following Day 1 Cycle and Cycle 2 (each cycle is 28 days)]

  10. Trough Concentrations of AB680

    Measured: Multiple timepoints up to approximately 16 months

  11. Cmax EOI of Zimberelimab

    Measured: Multiple timepoints up to approximately 16 months

  12. AUV(0-336) of Zimberelimab

    Measured: Cycle 1 Day 1 up to 336 hours

  13. Trough Concentrations of Zimberelimab

    Measured: Multiple timepoints up to approximately 16 months

  14. Number of Participants With Anti-Drug Antibodies to the Biologic Component(s) of Combination Therapy

    Measured: Up to approximately 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start10 May 2021
  3. Primary completion5 Sep 2025
  4. Study completion5 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660812
Sponsor's protocol ID
ARC-9
Other IDs
2020-005386-13
Acronym
ARC-9
Status last verified
May 2025
First submitted
3 Dec 2020
Last updated
20 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AB680, Etrumadenant and Zimberelimab in people with Metastatic Colorectal Cancer, run by Arcus Biosciences, Inc. at 44 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, South Korea, France, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort A and B - Progression-free Survival (PFS) (time frame: From randomization until death from any cause (up to approximately 3-7 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04660812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.

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